NDC 49288-0810

Treatment Set TS340526

Treatment Set Ts340526

Treatment Set TS340526 is a Intradermal; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Antigen Laboratories, Inc.. The primary component is Cynodon Dactylon Pollen; Iva Annua Var. Annua Pollen; Acer Negundo Pollen; Poa Pratensis Pollen; Plantago Lanceolata Pollen; Juniperus Virginiana Pollen; Populus Deltoides Pollen; Carya Illinoinensis Pollen; Betula Nigra Pollen; Fraxinus Americana Pollen; Carya Tomentosa Pollen; Quercus Alba Pollen; Sorghum Halepense Pollen; Kochia Scoparia Pollen; Chenopodium Album Pollen; Amaranthus Retroflexus Pollen; Ambrosia Trifida Pollen; Ambrosia Artemisiifolia Pollen; Ambrosia Psilostachya Pollen.

Product ID49288-0810_ae8520ee-f4a4-4de4-9d2d-bccc97d30931
NDC49288-0810
Product TypeHuman Prescription Drug
Proprietary NameTreatment Set TS340526
Generic NameTreatment Set Ts340526
Dosage FormInjection, Solution
Route of AdministrationINTRADERMAL; SUBCUTANEOUS
Marketing Start Date1986-10-31
Marketing CategoryBLA / BLA
Application NumberBLA102223
Labeler NameAntigen Laboratories, Inc.
Substance NameCYNODON DACTYLON POLLEN; IVA ANNUA VAR. ANNUA POLLEN; ACER NEGUNDO POLLEN; POA PRATENSIS POLLEN; PLANTAGO LANCEOLATA POLLEN; JUNIPERUS VIRGINIANA POLLEN; POPULUS DELTOIDES POLLEN; CARYA ILLINOINENSIS POLLEN; BETULA NIGRA POLLEN; FRAXINUS AMERICANA POLLEN; CARYA TOMENTOSA POLLEN; QUERCUS ALBA POLLEN; SORGHUM HALEPENSE POLLEN; KOCHIA SCOPARIA POLLEN; CHENOPODIUM ALBUM POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA TRIFIDA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA PSILOSTACHYA POLLEN
Active Ingredient Strength16 [BAU]/mL; g/mL; g/mL; [BAU]/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL; g/mL
Pharm ClassesIncreased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Pollen [CS],Allergens [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 49288-0810-3

10 mL in 1 VIAL, MULTI-DOSE (49288-0810-3)
Marketing Start Date1986-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49288-0810-3 [49288081003]

Treatment Set TS340526 INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA102223
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1986-10-31
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
CYNODON DACTYLON POLLEN16 [BAU]/mL

OpenFDA Data

SPL SET ID:77dae1e5-e616-43a8-8618-82bd90efa494
Manufacturer
UNII
Pharm Class PE
  • Cell-mediated Immunity [PE]
  • Increased IgG Production [PE]
  • Increased Histamine Release [PE]
    • PHarm Class EPC
  • Non-Standardized Fungal Allergenic Extract [EPC]
    • NUI Code
  • N0000185001
  • N0000175629
  • N0000171131
  • N0000185372
  • N0000169106
  • N0000184306

    • Pharmacological Class

    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Standardized Pollen Allergenic Extract [EPC]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Increased IgG Production [PE]
    • Pollen [CS]
    • Allergens [CS]
    • Non-Standardized Pollen Allergenic Extract [EPC]
    • Increased Histamine Release [PE]
    • Cell-mediated Immunity [PE]
    • Pollen [CS]
    • Allergens [CS]
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